(207 days)
Not Found
No
The summary describes a low-level laser system for fat reduction and does not mention any AI or ML components in its description, operation, or performance studies.
No.
The device is indicated for non-invasive temporary reduction in waist circumference for aesthetic use, not for treating a disease or condition.
No
Explanation: The device is described as being used for "non-invasive temporary reduction in waist circumference" and for "aesthetic use". Its function involves disrupting adipocyte cells to release fat and lipids, which is a therapeutic or aesthetic function, not a diagnostic one.
No
The device description explicitly details hardware components including a control unit, connection leads, paddles containing laser diodes, probes, and attachment straps. It is a physical system that utilizes software for control, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device uses low-level lasers applied externally to the skin for the non-invasive temporary reduction of waist circumference. It works by disrupting fat cells and releasing lipids, not by analyzing biological samples.
- Intended Use: The intended use is for "non-invasive aesthetic use" and "temporary reduction in waist circumference," which is a physical treatment, not a diagnostic test.
- Device Description: The description focuses on the physical components of the laser system (control unit, paddles, probes, etc.) and how it applies laser energy to the body.
- Performance Studies: The performance study describes measuring changes in waist circumference after treatment, not the results of a diagnostic test on a biological sample.
Therefore, this device falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Low level Laser model Strawberry and Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
Product codes (comma separated list FDA assigned to the subject device)
OLI
Device Description
The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system consists of a control unit, various connection leads up to 10 paddles, 2 probes, various "Velcro" attachment straps and other accessories. (A full list of system contents is included at the end of this section.)
A paddle is a device containing six cold red laser emitting diodes which is designed to be placed on the skin. The system can operate using 4, 6, 8 or 10 paddles that are connected to the control unit.
A probe is a device containing one cold red laser emitting diode which is designed to be placed on the skin to treat specific smaller areas of fat, where a usual flat paddle won't ergonomically fit.
The control unit is an electrically powered unit (100-240v, 50-60Hz auto-ranging). enabled by a main switch and key switch. Once enabled it is controlled using a button (Strawberry) or touchscreen (Strawberry and Cream) interface. The output of the diode (six per paddle) is limited to 40mW +/- 15% by a power limiting PCB from the central processing unit.
When the laser paddles are placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells are therefore reduced in size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Around the subjects abdomen (at the height of the iliac crest)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Double blind clinical study: Laser Lipo Ltd, at the request of the CDRH, had a full double blind clinical study carried out using a total of 35 subjects. Of these, 22 subjects received active laser treatments, and the remaining 13 subjects received placebo treatments. (See section 20.)
Conclusions: At the conclusion of the study, it was clear that 95% of the actively treated subjects achieved, or met, the success criteria. The criteria was set as achieving a temporary reduction around the subjects abdomen (at the height of the iliac crest) of 1.6in (4cm). The average recorded loss was 3.68in (9.35cm) with the greatest loss at 5.6in (14.22cm). Out of the 22 treated subject one failed to met the criteria with a reduction of only 1.2in (3cm). Thus proving the efficacy of the Strawberry and Strawberry & Cream inch loss device.
Not one of the placebo subjects achieved more than 1.3in (3.3cm).
No adverse effects were experienced by any of the trial subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 95% of actively treated subjects achieved or met the success criteria.
- Average recorded loss: 3.68in (9.35cm)
- Greatest loss: 5.6in (14.22cm)
- Only one out of 22 treated subjects failed to meet the criteria with a reduction of 1.2in (3cm).
- Not one of the placebo subjects achieved more than 1.3in (3.3cm).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
0
K13034
September 05, 2013
Center for Devices and Radiological Health
Laser Lipo Ltd Heath House, Crockham Hill Edenbridge United Kingdom, TN8 6ST Telephone: +44 844 980 1820 e-mail: ian@strawberry-laser.com
ﻏﺴ
Image /page/0/Picture/3 description: The image shows a black and white drawing of a strawberry. The strawberry is depicted with its characteristic shape and texture, including the small seeds on its surface. The top of the strawberry has a leafy green stem. The drawing style is somewhat rough, with visible strokes and shading that give the strawberry a three-dimensional appearance.
510[k] Summary
as required by section 807.92(c)
Owner's Name SEP 0 6 2013 Laser Lipo Ltd Address: Heath House Crockham Hill Edenbridge Kent TN8 6ST United Kingdom Tel: 011 44 844 980 1820 Mobile: 011 44 777 445 9611 Fax: 011 44 1732 866 231 Contact Person: Ian Cobley at Laser Lipo Ltd Tel : 011 44 844 980 1820 011 44 777 445 9611 Mobile: Fax: 011 44 844 980 1820 ian@strawberry-laser.com E-mail: . Date this summary was prepared: January 31, 2013
Classification name: Low Level laser system for aesthetic use, 21 CFR 878.5400 79 OLI
Common/Usual Name: Low Level laser system for aesthetic use
Proprietary Name: Laser Lipo Ltd will manufacture two devices:
- The Strawberry low level laser system model ILO, and, ●
- The Strawberry & Cream low level laser system model SC �
1
, t
Establishment Registration Number:
The Strawberry low level laser system and Strawberry & Cream low level laser system will be manufactured by: Laser Lipo Ltd
Heath House Crockham Hill Edenbridge Kent TN8 6ST United Kingdom 011 44 844 980 1820 011 44 844 980 1820
Establishment Registration Number: To be applied for following clearance of this submission.
Substantial Equivalence: The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system is substantially equivalent in design, use and materials to the: Chromogenex Technologies Ltd I-Lipo System - K111501
- . They are made of the similar materials
Telephone:
Fax:
- They have similar indications for use that are achieved through the same . technology
- 0 They are assembled from similar components
- They have similar user input and output interfaces and .
- Have similar features. .
In particular both the Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system and the Chromogenex Technologies Ltd i-Lipo System:
- use laser diodes .
- o of approximately 660 nm wavelength, and
- o less than 50 mW output
- . incorporated into
- o multiple multi-diodes "paddles" attached to the subject with special straps
Strawberry 4 to 10 paddles with 6 diodes each i-Lipo 4 paddles with 9 diodes each
- o and both have two probes with one diode each
- � have a similar control unit
- o LCD subject display
- o membrane key pad inputs
2
ﺗ
- 0 incorporated into display as a touch screen for strawberry and cream o microprocessor controlled through software
- o multi-range power supply (EU and US voltages and frequencies)
- . have a similar range of connecting cables
- have the same laser protection goggles ●
- o different name printed on outside of frame
Description of Product:
The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system consists of a control unit, various connection leads up to 10 paddles, 2 probes, various "Velcro" attachment straps and other accessories. (A full list of system contents is included at the end of this section.)
A paddle is a device containing six cold red laser emitting diodes which is designed to be placed on the skin. The system can operate using 4, 6, 8 or 10 paddles that are connected to the control unit.
A probe is a device containing one cold red laser emitting diode which is designed to be placed on the skin to treat specific smaller areas of fat, where a usual flat paddle won't ergonomically fit.
The control unit is an electrically powered unit (100-240v, 50-60Hz auto-ranging). enabled by a main switch and key switch. Once enabled it is controlled using a button (Strawberry) or touchscreen (Strawberry and Cream) interface. The output of the diode (six per paddle) is limited to 40mW +/- 15% by a power limiting PCB from the central processing unit.
When the laser paddles are placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells are therefore reduced in size.
3
Intended use:
The Low level Laser model Strawberry and Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
Performance Data:
Laser wavelength and output has been demonstrated to be capable and substantially equivalent to the predicate device (Chromogenex i-Lipo, K 111051).
| Test | Mean | Quantity | Sample
Standard
Deviation | Capability,
Cp |
|-------------------------------------------------------------------------------------------------------------------------------------|-----------|----------|---------------------------------|--------------------|
| Laser diode power output:
Paddle Laser diode output
is set to 40mw +/-15%. | 39.35 | 1140 | 0.81 | 2.47 |
| Probe Laser diode output
is set to 40mw +/-15%. | 39.02 | 40 | 0.72 | 3.49 |
| EU portable appliance
testing | 100% pass | 20 | | |
| Visual Inspection:
• external components,
cables, outer casings
and the
• General condition of
all associated parts. | 100% pass | 20 | | 100%
inspection |
| Assembly tests | 100% pass | 20 | | 100%
inspection |
| Functionality tests | 100% pass | 20 | | 100%
inspection |
Double blind clinical study: Laser Lipo Ltd, at the request of the CDRH, had a full double blind clinical study carried out using a total of 35 subjects. Of these, 22 subjects received active laser treatments, and the remaining 13 subjects received placebo treatments. (See section 20.)
Conclusions: At the conclusion of the study, it was clear that 95% of the actively treated subjects achieved, or met, the success criteria. The criteria was set as achieving a temporary reduction around the subjects abdomen (at the height of the iliac crest) of 1.6in (4cm). The average recorded loss was 3.68in (9.35cm) with the greatest loss at 5.6in (14.22cm). Out of the 22 treated subject one failed to met the criteria with a reduction of only 1.2in (3cm). Thus proving the efficacy of the Strawberry and Strawberry & Cream inch loss device.
Not one of the placebo subjects achieved more than 1.3in (3.3cm).
No adverse effects were experienced by any of the trial subjects.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
September 6, 2013
Laser Lipo Ltd Mr. Ian Coblev Heath House, Crockham Hill Edenbridge. Kent TN8 6ST United Kingdom
Re: K130341
Trade/Device Name: Laser Lipo Ltd Strawberry Low Level Laser system and Strawberry and Cream Low level Laser system Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OLI Dated: July 26. 2013 Received: July 29, 2019
Dear Mr. Cobley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
5
Page 2 - Mr. Ian Cobley
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default,htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K130341
Device Name: Laser Lipo Ltd Strawberry Low Level Laser system and Strawberry and Cream Low level Laser system
Indications for Use: The Low level Laser model Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
Prescription Use __ X_
AND/OR
Over-The-Counter Use
{Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.09.06 11:33:42 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number_K130341